BIOSIMILARS

A case in point is Amgen’s Neulasta On-body Injector. “Traditionally you have to go to a doctor’s office or cancer therapy center to be infused with this drug,” said Ginestro, “but they’ve developed a drug development technology that will allow you to self-administer at home. That’s a way for them to create a stickier product in the marketplace.”

Another tactic is to increase the medication price prior to patent expiration in anticipation of competing drugs on the way, and then to discount the price once these competitors are actually on the market.

Overseas Expertise

While biosimilars and their original counterparts duke it out in the US, it remains to be seen just how much cost savings will actually trickle down to insurers and patients. If looking to the one and only currently on the US market for a clue, Ginestro said that Zarxio is being sold at a 15% discount. “I think a lot of people were expecting that it would be discounted more than that,” he noted, “but the fact that they’re the only other player, I think Sandoz feels like it is in a position where it can gain a share without a heavy discount.”

For more in the way of examples and lessons learned, many are turning to Europe, where biosimilars were first introduced a decade ago. Overseas, there is a large price discount on filgrastim, both on the reference product Neupogen and on the multiple biosimilars on the market, Ginestro said, which has led to significant savings. And, generally speaking, the more versions there are of any one drug on the market, the steeper the discounts.

It’s a dynamic that can impact drug utilization. Although, ideally, patients with cancer would always be able to receive the drugs that they need, when biosimilars came on the market and prices dropped, utilization actually went up in some cases. The conclusion is that there were cancer patients that either weren’t getting their drugs or weren’t getting enough. “Cost is a market access barrier,” Ginestro said. “At some point in the chain, somebody was making a decision based on price about how much or how often and whether to prescribe.”

While Europe has shown that biosimilar launches are not like generic or branded launches—and that product uptake can vary widely based on the dynamics of the individual medication, the market, and the competitive landscape—it is clear that the United States is a whole other ballgame. These factors also help to explain why it has taken so long for biosimilars to actually hit the market.

In some countries in which there is a single-payer system, the government is the one customer. As a result, these governments are very motivated to reduce costs and will do what is needed to push legislation through and clear up any uncertainties in litigation disputes. According to Ginestro, the United States has “a much more fragmented and complex regulatory environment and a much more complex political environment and reimbursement environment.” As such, the path to biosimilar adoption has taken longer to get through the US Congress, the FDA, and the Centers for Medicare and Medicaid Services (CMS).

The Big Unknown

One of the main differences between generic pharma and biosimilars is that interchangeability has not yet been established for biosimilars. Initially, the ones that have already been approved and will likely be approved in the United States are not interchangeable, and the view is that they won’t be, Ginestro said.

In cases where interchangeability is allowed, the prescribing pharmacist can automatically substitute a biosimilar drug for the biologic indicated on the provider’s subscription without a doctor’s approval. Many payers and biosimilar manufacturers are pushing to establish clarity on what is needed to get to this point.

Encouraging and promoting clarity around interchangeability is probably the biggest aspect payers should be focusing on moving forward, Ginestro added, along with encouraging education among the provider force about the benefits of biosimilar products.